November 28th 2023
Ogsiveo will be available within five to 10 business days to treat patients with desmoid tumors. It will launch with a price of $29,000 for a 30-day supply.
November 21st 2023
Janssen is seeking approval for use after Tagrisso in patients with metastatic non-small cell lung cancer.
A regulatory decision will not be made by the Prescription Drug User Fee Act (PDUFA) target action date of Dec. 16, 2023.
November 20th 2023
Truqap is an AKT kinase inhibitor that, along with Faslodex, reduced the risk of disease progression or death by 50%.
Contamination with Penicillium brevicompactum could lead to invasive fungal infections of the blood or pneumonia that can be life-threatening in immunocompromised patients.
FDA Approves Tibsovo Combination for Older Patients with Leukemia
Tibsovo is the first therapy targeting cancer metabolism for patients with newly diagnosed IDH1-mutated acute myeloid leukemia.
Prime Therapeutics’ Biosimilar Program Cut Expenses by 26%
Launched last year, Prime’s MedDrive is an integrated drug management solution that leverages biosimilars to help reduce drug spend.
FDA Accepts BLA for Mirvetuximab Soravtansine for Ovarian Cancer
The FDA has set a Prescription Drug User Fee Act (PDUFA) action date of Nov. 28, 2022.
Analysis Finds 2020 Drug Approvals Based on Smaller, Less Rigorous Trials
While regulatory flexibility is important for drugs for rare diseases, investigators are concerned the trend toward surrogate endpoints decreases confidence that new drugs can improve patient outcomes.
Janssen Updates Warnings Section of Imbruvica Label
The label for Imbruvica now includes information about the possibility of cardiac failure, which has occurred in 1% of patients. Imbruvica is used to treat B-cell blood cancers.
Fresenius Kabi Launches Generic of Velcade
Bortezomib is part of the company’s KabiConnect program, a recent expansion of its KabiCare patient support program
AstraZeneca’s Blockbuster Cancer Drug Granted Priority Review for Rare Cancers
The FDA’s Prescription Drug User Fee Act action date for its regulatory decision for Imfinzi for BTC is during the third quarter of 2022.
FDA Approves Enhertu for Earlier Use in Metastatic Breast Cancer
The FDA’s accelerated approval of Enhertu in later line HER2 positive metastatic breast cancer has now converted to regular approval.
FDA Issues CRL for Surufatinib for Rare Pancreatic Cancer
The FDA would like Hutchmed to conduct a multi-regional trial that includes patients who are more representative of the U.S. patient population and aligned to current U.S. medical practice.
FDA Issues CRL for Toripalimab
The regulatory agency has requested a quality process change for toripalimab, which is being developed to treat nasopharyngeal carcinoma.
CVS Specialty, Elixir Among Pharmacies Distributing Cancer Drug Lenvima
Lenvima is approved to treat thyroid cancer, renal cell carcinoma and in combination with Keytruda for metastatic kidney cancer.
NCCN Adds Vonjo to Guidelines for Myeloproliferative Neoplasms
Vonjo is the first therapy that specifically addresses the needs of patients with cytopenic myelofibrosis, a bone marrow cancer.
Accord BioPharma Launches Camcevi for Advanced Prostate Cancer
Camcevi is the first ready-to-inject sterile formulation of leuprolide mesylate for subcutaneous injection that comes in a pre-filled syringe with no mixing required.
FDA Approves Novartis’ Pluvicto for Advanced Prostate Cancer
Pluvicto is the first targeted radioligand therapy for treatment of progressive, PSMA-positive metastatic castration-resistant prostate cancer.
FDA Issues CRL for Lilly’s Sintilimab for First-Line NSCLC
The FDA has asked for an additional clinical trial with overall survival as the endpoint.
FDA Approves Keytruda for Advanced Endometrial Cancer
The FDA also approved a companion diagnostic to select patients with mismatch repair deficiency who would be eligible for treatment with Keytruda.
BMS’s Opdualag Snags Approval for Melanoma
Opdualag is a first-in-class immunotherapy that combines Opdivio with the novel LAG-3-blocking antibody relatlimab.
Merck Discontinues Keytruda Combo Trial for Prostate Cancer
In an interim analysis, Keytruda/Lynparza did not improve overall survival in patients with metastatic castration-resistant prostate cancer who progressed after treatment with chemotherapy.
Cabometyx Combo Doesn’t Meet Survival Endpoint in Advanced Liver Cancer Trial
After a phase 3 trial showed that Cabometyx/atezolizumab did not improve overall survival in patients with hepatocellular carcinoma, Exelixis officials have said they won’t be submitting an NDA for untreated patients with advanced liver cancer.
FDA Approves Lynparza for Early Breast Cancer
Lynparza reduced the risk of death by 32% versus placebo. It is the first targeted treatment for patients with early breast cancer to be used after surgery or prior treatment.
NCCN Includes Besremi on Cancer Treatment Guideline
Besremi is included as an option to treat the rare blood disorder polycythemia vera regardless of treatment history and for use in both low- and high-risk settings.
Aadi Bioscience Selects PANTHERx Rare to Distribute Fyarro
Aadi Bioscience recently launched Fyarro, the first FDA-approved therapy to treat an ultra-rare sarcoma.
Teva Launches First Generic to Blockbuster Cancer Med
This is the first generic available for Revlimid in the United States.
FDA Okays a Third Biosimilar to Neupogen
Amneal Pharmaceuticals received approval for Releuko to decrease incidence of infection after chemotherapy.
Employers Face Barriers With Adopting Biosimilars
Despite the promise of savings billions of dollars in the United States, adoption of biosimilars has been slow. A roundtable discussion among employers highlighted some of the barriers, including formulary design and drug pricing and rebates.
NSCLC Drugs Raised Prices Despite Evidence of Price Competition
Price increases on promising non–small cell lung cancer drugs despite evidence price competition raise concerns about affordability.
Quality of Patient-Reported Outcomes in Oncology Trials Improves
Reporting of PRO in oncology clinical trials increased after standards from ISOQOL and others were published in 2013.
FDA Updates REMS for CAR T-Cell Therapies
Because of a COVID-19 related shortage, facilities may not have immediate access to Actemra, which is required as part of the REMS programs for CAR T-cell therapies.
New Data Supports COVID-19 Booster for Blood Cancer Patients
Blood cancer patients who had at least some antibodies after the first two doses are likely to produce large amounts after the third vaccination.
Secura Bio Withdraws U.S. Oncology Indications for Copiktra, Farydak
Both Copiktra and Farydak had received accelerated approvals, and the FDA had required confirmatory trials. Secura Bio has determined such trials are not feasible.
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